The therapy, currently approved in oral and injectable formulations, is being considered for adult women with symptoms.
A New Drug Application (NDA) has been submitted to the US Food and Drug Administration (FDA) for a nasal spray product candidate that could relieve symptoms in adult women with either acute or recurrent gastroparesis.
The metoclopramide nasal spray (Gimoti) from gastrointestinal (GI) disease specialty pharmaceutical company Evoke Pharma, had been successfully submitted for the FDA’s consideration last week, with expectation that a substantive review will be made available in early August.
The therapy is being investigated for the treatment of the GI disorder gastroparesis, which is characterized by a gastric delay that can compromise the body’s absorption of oral medications. It currently affects millions of patients worldwide, according to Evoke, and is in new of wider therapy options. Metoclopramide, as both an oral and injectable formulation, is the only drug currently approved to treated gastroparesis in the US.
In July 2016, Evoke announced phase 3 clinical trial results which showed meaningful benefits of Gimoti when administered to adult female patients with symptoms associated with acute and recurrent diabetic gastroparesis. The multicenter, randomized, double-blind, parallel group trial compared the therapy to a placebo control, and evaluated for efficacy, safety, and population pharmacokinetics.
Either therapy or placebo were administered 4 times daily for 28 days to patients, who completed a daily symptom diary. Though patients did not reach primary endpoint of change in average symptom severity score prior to baseline compared to Week 4 on treatment, Gimoti reported benefits in 51% of patients with moderate to severe symptoms at baseline. Patients receiving the therapy had clinically and statistically significant improvements in nausea and upper abdominal pain.
Dave Gonyer, president and chief executive officer of Evoke, said that women currently represent 80% of the entire patient population. Gimoti’s nasal spray delivery of the notably efficient motility and antiemetic drug could make a significant difference in patient quality of life.
“Vomiting and gastric emptying delays cause unpredictable absorption of food and oral medications which complicates glucose control and can lead to dehydration and malnutrition,” Gonyer said in a statement. "Existing oral treatment options may be ineffective during an acute flare, which we believe creates the need for a non-oral treatment option.”